MAUDE manufacturer profile
COLOPLAST A/S · OTP
MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Key facts
| Manufacturer | COLOPLAST A/S |
|---|---|
| Manufacturer group | COLOPLAST MANUFACTURING US, LLC |
| Product code | OTP |
| Product code name | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Pain, Insufficient Information, Prolapse, Adverse Event Without Identified Device or Use Problem, Incontinence, Erosion, Urinary Tract Infection, No Code Available Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1